Do you want to work with a company at the cutting edge of applied AI and Healthcare? Are you ready to be at the forefront of Mobile Technology development?
We are seeking a highly motivated and experienced Quality Manager with a focus on ISO 13485 to join our team. The ideal candidate will be responsible for leading and managing the quality program, ensuring that medical devices and related services meet or exceed customer requirements and industry standards.
If you have a passion for quality and innovation in healthcare and are looking for an exciting opportunity to grow your career in the Medical Devices sector, we encourage you to apply.
Position duties and obligations (responsibilities and requirements):
- Manage the maintenance of Quality Management documentation, including ISO 13485, Risk Management and other relevant standards and regulations
- Report to the management on the performance and status of the Quality Management System (QMS)
- Accompany the new and further development of our products on the regulatory side
- Conduct management reviews
- Execute internal audits and facilitate external audits
- Instruct and train employees in the QMS and support the product-relevant implementation of applicable legal requirements in cooperation with the divisional managers
- Keep up to date with all standards, regulatory requirements, and guidelines applicable and assess the impact on the organization and products
- Support teams in organizing and keeping technical files complete and up to date
- Assume the role of Management Representative (MR).
Necessary Competence (education/qualification):
- At least 2-3 years of experience with ISO 13485, ideally including Software Medical Devices
- Full professional fluency in English is a requirement as all company systems and operations are in English
- Bachelor’s degree or master’s degree in a relevant discipline.
- Professional Certification in Quality Management
- Minimal Professional Certification as Internal Auditor ISO 13485, preferably Lead Auditor
- Competence in Risk Management
- Experience in risk and project management
- Strong communication skills and an independent way of working
- Additional knowledge or working experience ISO 27001 cyber security, HIPAA, and GDPR would be very beneficial.
Here’s the deal
We focus on improving the lives of people with neurological diseases. It’s that simple. There’s no small print. No quick fixes. Just big ideas and a commitment to getting it done.
But if we can succeed in achieving that, while ensuring our team can grow and shares in this collective sense of worth, then despite the sometimes hectic days and deadlines/long days and late nights, we’ll sleep well.
Whether you are a seasoned pro, or just getting started, your time with us will be one of constant growth. Being MedTech means we are at the crossroads of a highly regulated world where every decision has every day impacts on patients’ lives.
We look forward to planning the future with you.